A Phase II multicentre, open-label study investigating the pharmacokinetics, pharmacodynamics, efficacy and safety of a loading dose regimen of a new GnRH antagonist, Teverelix 90 mg, long-acting formulation administered intramuscularly in patients with advanced prostate cancer
- Conditions
- advanced prostate cancer
- Registration Number
- EUCTR2004-001648-64-LT
- Lead Sponsor
- ardana LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 14
• histologically proven adenocarcinoma of the prostate
• androgen deprivation therapy suitable (advanced prostate cancer i.e. with local invasion or/and metastasis)
• signed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• liver or renal function tests (ASAT/SGOT, ALAT/SGPT, total bilirubin, creatinine) exceeding twice the upper limit of the normal range, unless the elevation is attributed to hepatic metastasis
• any contraindication to the use of teverelix
• life expectancy of less than 1 year
• baseline testosterone value below 8 nmol/l
• bilateral orchidectomy
• pre-existing hormone therapy or planned concomitant use of androgen deprivation therapy with any agent other than the investigational drug
• neurological, psychiatric disease, drug or alcohol abuse which could interfere with the subject’s proper compliance
• evidence of concurrent malignancy
• exposure to another investigational agent within the last month
• lack of ability or willingness to give informed consent
• anticipated non-availability for study visits/ procedures
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to assess the duration of action of an initial loading” dose regimen of Teverelix LA in terms of suppression of testosterone to below castrate level (0.5 ng/ml – 2 nmol/l);Secondary Objective: • to assess the pharmacodynamics of teverelix in terms of ability to suppress and to maintain plasma testosterone levels below castration level (< 0.5ng/ml = 2nmol/l) until (after week 3) 2 consecutive, increasing T levels above castration level with the latter one above 2 ng / ml have been recorded.<br>• to assess the effects on Luteinizing Hormone (LH)<br>• to assess the effects on Prostate Specific Antigen (PSA)<br>• to assess the safety of Teverelix LA in terms of :<br>o local tolerability and <br>o systemic tolerability (adverse events and changes in laboratory parameters)<br>;Primary end point(s):
- Secondary Outcome Measures
Name Time Method